Regulatory affairs-officer
Posted on: 2010-12-09
From Onwards I am working with Astra lifecare (India) Pvt. Ltd, ahmedabad from last 11 months
job resposibility:|
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Preparation and review of the dossiers as per the current prescribed guidelines of the respective regulatory authorities. |
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Collection of various pharmacological, pre-clinical & toxicological data. |
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Review of the quality and analytical data as per the pharmacopoeia, specification, MOA, STP, batch records, Stability, Finished product / Packaging material data for the purpose of compilation of the dossier. |
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Co-ordinating in sample management and submission to the regulatory authorities. |
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Maintenance of the office copies of the sent dossiers / documents/samples. |
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Perform additional regulatory related duties as and when required, assigned by the IRA team leader. |
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Preparation / Review of labelling & packaging material, Packing inserts the finish formulation marketing materials, promotion materials under supervision. |
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Provide regulatory support / inputs to various departments as and when required. |
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Preparation of dossiers for Medical devices. |
r M. Pharm. Part II (Pharmaceutical chemistry) from ABMRCP Bangalore, RGUHS, Bangalore: 77.00% (Distinction)
r M.Pharm. Part I (Pharmaceutical Chemistry) from ABMRCP Bangalore, RGUHS, Bangalore in 2009 : 77.25% (Distinction)
r B. Pharm. from RGUHS,Mangalore in2007: 70.00% (Distinction)
r HSC form A-One High school,Ahmedabad in 2002: 74%
r SSC from A-One High school,Ahmedabad in 2010: 82.29% (Distinction)
ADDITIONAL QUALIFICATIONr Taken pharma training for 3 months under Karnataka pharmaceutical trust, Bangalore for 3 months during M.pharm which involved Intellectual property right (IPR), Dossier preparation for registration of drug, ICH guidelines(Q8, Q9, Q10),Pharmaceutical manufacturing processes(solid, parentrals, liquid orals), Pharmaceutical testing & specifications, Validation, Calibration, CAPA, Deviation, Analytical method development stability guidelines, Clinical trials, Pharmaceutical packaging,.
r Attended seminar on Quality management system and Quality risk management given by Mr S.M. Mudda executive vice president from Micro labs.
sKILLS AND PRACTICAL KNOWLEDGEr Synthesis of compounds
r Prediction of ultraviolet, IR, NMR and Mass Spectroscopic data
r Designing of molecules by QSAR & Molecular Docking studies.
r Follow through with a plan or decision.
r Indentify problems and needs.
iNSTRUMENTS HANDLED
r UV (Shimadzu)-1700
r FT-IR (Bruker) Tensor-27
r Dissolution apparatus
r Disintegration apparatus
r Microwave Oven
SOFTWARE’S KNOWLEDGEr Molegro virtual docker
r Hyperchem,
r ACD Chem Sketch, ChemDraw, ISIS Draw
m.PHARM PROJECT:Research Topic: “Synthesis, chereterization and pharmacological activity of few substituted pyridine derivatives.”
r Abstract: 1,4-Dihydropyridine and its heterocyclic derivatives have shown diverse chemical reactivity and broad spectrum pharmacological activity. They are reported to possess important therapeutic properties such as antagonist of a platelet activating factor, novel nonpeptidic HIV-1 protease inhibitor, antimicrobial, bronchodilatory, anticonvulsant etc.
r Synthesis: Preparation of 1,4-dihydro Pyridine was prepared by Microwave Tecnique in which undergoes mannich reaction with sulphanilamide, reaction mixture was reacted with Schiff base to give different aldehyde derivatives which was cyclised by mercapto acetic acid to give different thiazolines.
r Pharmacological Activity: synthesized novel 12 derivatives were screened for analgesic activity in Swiss mice, anti-inflammatory activity in Wistar rats, in vitro antibacterial and antifungal activity and antitubercular activity. Some compounds found to be moderate pharmacological activity. And some shows comparable activity with standard.
iNDUSTRIAL TRANINGr Cadila Pharmaceuticals Ltd, Ahmadabad
r Micro labs(Parentral Unit), Bangalore
r Kamwell pharmaceuticals, Bangalore
r R M fine chemicals, Bangalore
PRESENTATION AND CONFERENCES ATTENDEDr Attended 61th Indian Pharmaceutical Congress-2009 held at Ahemdabad.
r Attended 2nd Annual Convection of Association of Biotechnology and Pharmacy & National Seminar on “Pharmacogenomics and its Application in Drug Discovery,” 24-25 Jan. 2009 at Acharya & B. M. Reddy College of Pharmacy, Bangalore Attended 2nd IPA Students` Congress, organized by Acharya & B. M. Reddy College of Pharmacy, Bangalore
r Attended 60th Indian Pharmaceutical Congress-2008 held at Delhi.
r Attended seminar on “green chemistry” held at Mysore.
PRESENTATION
r Poster presented on “Recent approches in combinatorial chemistry in 2nd Annual Convection of Association of Biotechnology and Pharmacy at Bangalore.
r Poster presented on “Synthesis and antimicrobial activity of 1,4-dihydropyridine derivatives” in 2nd IPA Students` Congress seminar held by IPA at Bangalore.
r Poster presented on “Recent approches in Green chemistry” in IPA seminar at Mysore.
Association membership
r A registered member of Karnataka State Pharmacy Council.
r A registered member of Indian Pharmaceutical Association (IPA)
POSITIONS OF RESPONSIBILITYSelected as an IR in charge to operate IR Spectrometer in College
r Academic Award:
ü 3nd rank in Poster presentation on on “Recent approches in combinatorial chemistry at 2nd Annual Convection of Association of Biotechnology and Pharmacy & National Seminar on Pharmacogenomics and its Application in Drug Discovery; 24-25 Jan. 2009 at Bangalore.
Area of intrest:- Regulatory affairs
- Quality assurance
- Date of Birth 24th April 1986
- Father’s name Patel Jayeshkumar P
- Gender Female
- Marital Status Single
- Languages English, Hindi & Gujrati.
- Nationality Indian
DECLARATION
I hereby declare that the above-mentioned information is correct to the best of my knowledge and belief.
Patel Ruchi Jayeshkumar